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Liver Transplantation After ex Vivo Liver Perfusion (EVOLVE)

Primary Purpose

Liver Transplant; Complications, Transplant; Failure, Liver, Transplant Dysfunction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Liver transplantation
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Transplant; Complications focused on measuring Liver, Transplantation, Perfusion, Dual-end-ischemic Hypothermic Oxygenated Perfusion, Normothermic Machine Perfusion, Controlled Oxygenated Rewarming, Microdialysis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent ≥ 18 years Indication for liver transplantation (one criteria must be met): Colorectal cancer patients who have received 1st and 2nd line chemotherapy where the treatment has been stopped due to progression or toxicity and the patient is not eligible for SECA-2 (Survival Following Liver Transplantation for Patients With Nonresectable Liver-only Colorectal Metastases) study. Hepatocellular carcinoma patients who are not suitable for standard liver transplantation, liver resection or local treatment (Transarterial Chemoembolisation or Selective internal radiotherapy). The patients must have progression or intolerance (toxicity) for immune checkpoint inhibitors or 1st line treatment. Cholangiocarcinoma patients who have progression or intolerance to first-line chemotherapy. Benign liver disease with urgent need for transplantation within months, but no regular graft is available. Life expectancy ≤ 6 months Willing, able and expected cooperation to attend follow-up examinations Patients who have a need for liver transplantation but cannot participate in other transplant studies or participation in another clinical trial with randomization to liver transplantation. For malignant disease the following criteria must be met: Good performance status assessed at the discretion of the treating physician. ECOG (Eastern Cooperative Oncology Group) 0 or 1 Satisfactory blood tests Hemoglobin >8 g/dl Neutrophiles >1.0 (after any Granulocyte colony-stimulating factor) Platelets >75 Bilirubin <1.5 x upper normal level ASAT (Aspartate aminotransferase), ALAT (alanine aminotransferase) <5 x upper normal level Albumin above lower normal level. Exclusion Criteria: Already listed for ordinary Ltx with expectance of getting offered a regular liver graft within a reasonable time-frame. Patients included in the control arm of the SECA-3 study or the Excalibur studies except for the Ltx arm of the Excalibur I study. Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial. Any reason why, in the opinion of the investigator, the patient should not participate.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Liver transplanted patient

    Non-liver transplanted patient

    Arm Description

    Patients who are transplanted with an ECD liver after pretreatment with a liver perfusion machine

    Patients who are not offered a liver transplantation during the inclusion period

    Outcomes

    Primary Outcome Measures

    Lactate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
    Lactate level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.

    Secondary Outcome Measures

    Lactate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
    Microdialysis lactate level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
    Lactate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Microdialysis lactate level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Pyruvate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Microdialysis pyruvate level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Glycerol level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Microdialysis glycerol level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Glucose level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Microdialysis glucose level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Lactate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
    Microdialysis lactate level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Glycerol level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
    Microdialysis glycerol level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Glucose level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
    Microdialysis glucose level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Pyruvate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
    Microdialysis pyruvate level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
    Microdialysis glucose level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
    Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
    Microdialysis glucose level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
    Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
    Microdialysis pyruvate level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
    Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
    Microdialysis pyruvate level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
    Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
    Microdialysis glycerol level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
    Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
    Microdialysis glycerol level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
    Lactate level in microdialysate from bile after normothermic machine perfusion - 4 hours
    Microdialysis lactate level from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
    Lactate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
    Microdialysis lactate level from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
    Glucose level in microdialysate from bile after normothermic machine perfusion - 4 hours
    Microdialysis glucose levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
    Glucose level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
    Microdialysis glucose levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
    Pyruvate level in microdialysate from bile after normothermic machine perfusion - 4 hours
    Microdialysis pyruvate levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
    Pyruvate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
    Microdialysis pyruvate levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
    Glycerol level in microdialysate from bile after normothermic machine perfusion - 4 hours
    Glycerol levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
    Glycerol level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
    Glycerol levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
    Glycerol level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
    Glycerol levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
    Glucose level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
    Glucose levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
    Lactate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
    Lactate levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
    Pyruvate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
    Pyruvate levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
    Pyruvate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Pyruvate levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
    Glycerol level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Glycerol levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
    Lactate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Lactate levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
    Glucose level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Glucose levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
    Bile gases pH - 4 hours after normothermic machine perfusion
    Bile gas pH - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases pH - 2.5 hours after normothermic machine perfusion
    Bile gas pH - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases Lactate - 4 hours after normothermic machine perfusion
    Bile gas Lactate - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases Lactate - 2.5 hours after normothermic machine perfusion
    Bile gas Lactate - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases Glucose - 4 hours after normothermic machine perfusion
    Bile gas Glucose - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases Glucose - 2.5 hours after normothermic machine perfusion
    Bile gas Glucose - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases Oxygen (O2) - 4 hours after normothermic machine perfusion
    Bile gas O2 - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases O2 - 2.5 hours after normothermic machine perfusion
    Bile gas O2 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases carbon dioxide (CO2) - 4 hours after normothermic machine perfusion
    Bile gas CO2 - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases CO2 - 2.5 hours after normothermic machine perfusion
    Bile gas CO2 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases bicarbonate (HCO3) - 4 hours after normothermic machine perfusion
    Bile gas HCO3 - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases HCO3 - 2.5 hours after normothermic machine perfusion
    Bile gas HCO3 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases base excess (BE) - 4 hours after normothermic machine perfusion
    Bile gas BE - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Ischemia/reperfusion injury - 4 hours after normothermic machine perfusion
    Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Ischemia/reperfusion damage - 4 hours after normothermic machine perfusion
    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Ischemia/reperfusion injury - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Ischemia/reperfusion injury in liver biopsies, graded according to Tian Y et al et al, Liver transplant 2015; nil, mild, moderate, and severe. - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Ischemia/reperfusion damage - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Ischemia/reperfusion injury - before machine perfusion
    Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - before machine perfusion in extended criteria donors livers
    Ischemia/reperfusion damage - before machine perfusion
    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - before machine perfusion in extended criteria donors livers
    Ischemia/reperfusion injury - after controlled oxygenated rewarming machine perfusion - 1 hour
    Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe - after controlled oxygenated rewarming machine perfusion - 1 hour in extended criteria donors livers
    Ischemia/reperfusion damage - after controlled oxygenated rewarming machine perfusion - 1 hour
    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - after controlled oxygenated rewarming machine perfusion - 1 hour in extended criteria donors livers
    Ischemia/reperfusion injury - 2.5 hours after normothermic machine perfusion
    Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Ischemia/reperfusion damage - 2.5 hours after normothermic machine perfusion
    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases BE - 2.5 hours after normothermic machine perfusion
    Bile gas BE - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases oxygen saturation (SO2) - 4 hours after normothermic machine perfusion
    Bile gas SO2- 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases SO2 - 2.5 hours after normothermic machine perfusion
    Bile gas SO2- 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases hemoglobin (Hb)- 4 hours after normothermic machine perfusion
    Bile gas Hb - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases Hb - 2.5 hours after normothermic machine perfusion
    Bile gas Hb - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases sodium (Na) - 4 hours after normothermic machine perfusion
    Bile gas Na - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases Na - 2.5 hours after normothermic machine perfusion
    Bile gas Na - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases potassium (K) - 4 hours after normothermic machine perfusion
    Bile gas K - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases K - 2.5 hours after normothermic machine perfusion
    Bile gas K - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases Calcium (Ca) - 4 hours after normothermic machine perfusion
    Bile gas Ca - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gases Ca - 2.5 hours after normothermic machine perfusion
    Bile gas Ca - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Markers of injury, inflammation - 2.5 hours after normothermic machine perfusion
    Markers of injury, inflammation - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Bile gas lactate 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Bile gas lactate 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Markers of injury, inflammation 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Markers of injury, inflammation 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Bile gas Glucose 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Bile gas Glucose 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Bile gas pH 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Bile gas pH 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Bile gas O2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Bile gas O2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Bile gas CO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Bile gas CO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Bile gas HCO3 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Bile gas HCO3 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Bile gas SO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Bile gas SO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Bile gas Hemoglobin 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Bile gas Hemoglobin 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Bile gas Na 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Bile gas Na 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Bile gas K 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Bile gas K 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Bile gas Ca 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Bile gas Ca 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Bile gas BE 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Bile gas BE 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion
    Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Bile gas lactate 1 hour after controlled oxygenated rewarming machine perfusion
    Bile gas lactate 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Bile gas Glucose 1 hour after controlled oxygenated rewarming machine perfusion
    Bile gas Glucose 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Bile gas pH 1 hour after controlled oxygenated rewarming machine perfusion
    Bile gas pH 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion
    Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Bile gas O2 1 hour after controlled oxygenated rewarming machine perfusion
    Bile gas O2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Bile gas CO2 1 hour after controlled oxygenated rewarming machine perfusion
    Bile gas CO2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Bile gas HCO3 1 hour after controlled oxygenated rewarming machine perfusion
    Bile gas HCO3 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Bile gas BE 1 hour after controlled oxygenated rewarming machine perfusion
    Bile gas BE 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Bile gas SO2 1 hour after controlled oxygenated rewarming machine perfusion
    Bile gas SO2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Bile gas hemoglobin 1 hour after controlled oxygenated rewarming machine perfusion
    Bile gas hemoglobin 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Bile gas Na 1 hour after controlled oxygenated rewarming machine perfusion
    Bile gas Na 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Bile gas K 1 hour after controlled oxygenated rewarming machine perfusion
    Bile gas K 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Bile gas Ca 1 hour after controlled oxygenated rewarming machine perfusion
    Bile gas Ca 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Perfusate gas Ca - during machine perfusion
    Perfusate gas Ca during machine perfusion in extended criteria donors livers.
    Perfusate gas pH - during machine perfusion
    Perfusate gas pH during machine perfusion in extended criteria donors livers.
    Perfusate gas SO2 - during machine perfusion
    Perfusate gas SO2 during machine perfusion in extended criteria donors livers.
    Perfusate gas O2 - during machine perfusion
    Perfusate gas O2 during machine perfusion in extended criteria donors livers.
    Perfusate gas CO2 - during machine perfusion
    Perfusate gas CO2 during machine perfusion in extended criteria donors livers.
    Perfusate gas K - during machine perfusion
    Perfusate gas K during machine perfusion in extended criteria donors livers.
    Perfusate gas Na - during machine perfusion
    Perfusate gas Na during machine perfusion in extended criteria donors livers.
    Perfusate gas BE - during machine perfusion
    Perfusate gas BE during machine perfusion in extended criteria donors livers.
    Perfusate gas HCO3 - during machine perfusion
    Perfusate gas HCO3 during machine perfusion in extended criteria donors livers.
    Perfusate gas hemoglobin - during machine perfusion
    Perfusate gas hemoglobin during machine perfusion in extended criteria donors livers.
    Perfusate gas lactate - during machine perfusion
    Perfusate gas lactate during machine perfusion in extended criteria donors livers.
    Perfusate gas glucose - during machine perfusion
    Perfusate gas glucose during machine perfusion in extended criteria donors livers.
    Postoperative complications
    According to Clavien Dindo Classification
    Length of stay
    Length of initial ICU and initial hospital stay is determined in days of admission following liver transplantation.
    Machine flow during controlled oxygenated rewarming
    Machine flow (millilitre/hour)
    Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion
    Machine flow (millilitre/hour)
    Machine pressure during controlled oxygenated rewarming
    Machine pressure ((millimetre Hg))
    Machine pressure during Dual-end-ischemic Hypothermic Oxygenated Perfusion
    Machine pressure ((millimetre Hg))
    Machine Fraction of oxygen during controlled oxygenated rewarming
    Machine fraction of oxygen (%)
    Machine Fraction of oxygen Dual-end-ischemic Hypothermic Oxygenated Perfusion
    Machine fraction of oxygen (%)
    Machine Resistance during controlled oxygenated rewarming
    Machine Resistance (millilitre/minute/millimetre Hg)
    Machine Resistance during Dual-end-ischemic Hypothermic Oxygenated Perfusion
    Machine Resistance (millilitre/minute/millimetre Hg)
    Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion
    Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion flow (millilitre/hour)
    Machine flow during normothermic machine perfusion
    Machine flow during normothermic machine perfusion (millilitre/hour)
    Machine flow during normothermic machine perfusion
    Machine flow during normothermic machine perfusion (millilitre/hour)
    Machine pressure during normothermic machine perfusion
    Machine pressure (millimetre Hg)
    Machine pressure during normothermic machine perfusion
    Machine pressure (millimetre Hg)
    Machine Fraction of oxygen during normothermic machine perfusion
    Machine fraction of oxygen (%)
    Machine Fraction of oxygen during normothermic machine perfusion
    Machine fraction of oxygen (%)
    Machine Resistance during normothermic machine perfusion
    Machine Resistance (millilitre/minute/millimetre Hg)
    Machine Resistance during normothermic machine perfusion
    Machine Resistance (millilitre/minute/millimetre Hg)
    Total preservation time
    Total preservation time (machine perfusion time)
    Alanine amino transferase in perfusate during machine perfusion
    Alanine amino transferase in perfusate during machine perfusion (U/Litre)
    Aspartate amino transferase in perfusate during machine perfusion
    Aspartate amino transferase in perfusate during machine perfusion (U/Litre)
    Alkaline phosphatase in perfusate during machine perfusion
    Aspartate amino transferase in perfusate during machine perfusion (U/Litre)
    Gamma-glutamyl transferase in perfusate during machine perfusion
    Gamma-glutamyl transferase in perfusate during machine perfusion (U/Litre)
    Urea in perfusate during machine perfusion
    Urea in perfusate during machine perfusion (millimol/Litre)
    Bilirubin in perfusate during machine perfusion
    Bilirubin in perfusate during machine perfusion (micromol/Litre)
    Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in perfusate during machine perfusion
    Different cytokines/interleukins, endothelium markers, miRNA's in perfusate during machine perfusion
    Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in liver tissue during machine perfusion
    Different cytokines/interleukins, endothelium markers, miRNA's in liver tissue during machine perfusion
    Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in bile during machine perfusion
    Different cytokines/interleukins, endothelium markers, miRNA's in bile during machine perfusion
    Histopathology - liver tissue. Mitochondrial function
    Histological analysis of parenchymal biopsies which are assessed for mitochondrial function.
    Histopathology - bile duct. Mitochondrial function
    Histological analysis of bile duct biopsies which are assessed for mitochondrial function.
    Histopathology - liver tissue. Perfusion/reperfusion injury
    Histological analysis of parenchymal biopsies which are assessed for perfusion/reperfusion injury
    Histopathology - bile duct. Perfusion/reperfusion injury
    Histological analysis of bile duct biopsies which are assessed for perfusion/reperfusion injury
    Histopathology - liver tissue. Cell death
    Histological analysis of parenchymal biopsies which are assessed for cell death
    Histopathology - bile duct. Cell death
    Histological analysis of bile duct biopsies which are assessed for cell death
    Histopathology - liver tissue. Inflammation
    Histological analysis of parenchymal biopsies which are assessed for inflammation
    Histopathology - bile duct. Inflammation
    Histological analysis of bile duct biopsies which are assessed for inflammation
    Histopathology - liver tissue. Metabolomics
    Histological analysis of parenchymal biopsies which are assessed for metabolomics
    Histopathology - bileduct. Metabolomics
    Histological analysis of bile duct biopsies which are assessed for metabolomics
    Histopathology - liver tissue. Lipidomics
    Histological analysis of parenchymal biopsies which are assessed for lipidomics
    Histopathology - bile duct. Lipidomics
    Histological analysis of bile duct biopsies which are assessed for lipidomics
    Histopathology - liver tissue. RNA sequencing
    Histological analysis of parenchymal biopsies which are assessed for RNA sequencing
    Histopathology - bile duct. RNA sequencing
    Histological analysis of bile duct biopsies which are assessed for RNA sequencing
    Histopathology - liver tissue. Endothelium properties
    Histological analysis of parenchymal biopsies which are assessed for endothelium properties
    Histopathology - bile duct. Endothelium properties
    Histological analysis of bile duct biopsies which are assessed for endothelium properties
    International normalized ratio on postoperative day 7
    Blood sample from recipient: International normalized ratio on postoperative day 7
    Alanine amino transferase postoperative day 0
    Alanine amino transferase postoperative day 0 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative day 0
    Aspartate amino transferase postoperative day 0 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative day 0
    Alkaline phosphatase postoperative day 0 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative day 0
    Gamma-glutamyl transferase postoperative day 0 in the donated recipients (U/Litre)
    Urea postoperative day 0
    Urea postoperative day 0 in the donated recipients (millimol/Litre)
    Bilirubin postoperative day 0
    Bilirubin postoperative day 0 in the donated recipients (micromol/Litre)
    Bilirubin postoperative day 1
    Bilirubin postoperative day 1 in the donated recipients (micromol/Litre)
    Bilirubin postoperative day 2
    Bilirubin postoperative day 2 in the donated recipients (micromol/Litre)
    Bilirubin postoperative day 3
    Bilirubin postoperative day 3 in the donated recipients (micromol/Litre)
    Bilirubin postoperative day 4
    Bilirubin postoperative day 4 in the donated recipients (micromol/Litre)
    Bilirubin postoperative day 5
    Bilirubin postoperative day 5 in the donated recipients (micromol/Litre)
    Bilirubin postoperative day 6
    Bilirubin postoperative day 6 in the donated recipients (micromol/Litre)
    Bilirubin postoperative day 7
    Bilirubin postoperative day 7 in the donated recipients (micromol/Litre)
    Urea postoperative day 1
    Urea postoperative day 1 in the donated recipients (millimol/Litre)
    Urea postoperative day 2
    Urea postoperative day 2 in the donated recipients (millimol/Litre)
    Urea postoperative day 3
    Urea postoperative day 3 in the donated recipients (millimol/Litre)
    Urea postoperative day 4
    Urea postoperative day 4 in the donated recipients (millimol/Litre)
    Urea postoperative day 5
    Urea postoperative day 5 in the donated recipients (millimol/Litre)
    Urea postoperative day 6
    Urea postoperative day 6 in the donated recipients (millimol/Litre)
    Urea postoperative day 7
    Urea postoperative day 7 in the donated recipients (millimol/Litre)
    Aspartate amino transferase postoperative day 1
    Aspartate amino transferase postoperative day 1 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative day 1
    Alkaline phosphatase postoperative day 1 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative day 1
    Gamma-glutamyl transferase postoperative day 1 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative day 2
    Alanine amino transferase postoperative day 2 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative day 2
    Aspartate amino transferase postoperative day 2 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative day 2
    Alkaline phosphatase postoperative day 2 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative day 2
    Gamma-glutamyl transferase postoperative day 2 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative day 3
    Alanine amino transferase postoperative day 3 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative day 3
    Aspartate amino transferase postoperative day 3 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative day 3
    Alkaline phosphatase postoperative day 3 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative day 3
    Gamma-glutamyl transferase postoperative day 3 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative day 4
    Alanine amino transferase postoperative day 4 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative day 4
    Aspartate amino transferase postoperative day 4 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative day 4
    Alkaline phosphatase postoperative day 4 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative day 4
    Gamma-glutamyl transferase postoperative day 4 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative day 5
    Alanine amino transferase postoperative day 5 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative day 5
    Aspartate amino transferase postoperative day 5 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative day 5
    Alkaline phosphatase postoperative day 5 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative day 5
    Gamma-glutamyl transferase postoperative day 5 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative day 6
    Alanine amino transferase postoperative day 6 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative day 6
    Aspartate amino transferase postoperative day 6 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative day 6
    Aspartate amino transferase postoperative day 6 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative day 6
    Gamma-glutamyl transferase postoperative day 6 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative day 7
    Alanine amino transferase postoperative day 7 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative day 7
    Aspartate amino transferase postoperative day 7 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative day 7
    Alkaline phosphatase postoperative day 7 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative day 7
    Gamma-glutamyl transferase postoperative day 7 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative month 1
    Alanine amino transferase postoperative month 1 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative month 1
    Aspartate amino transferase postoperative month 1 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative month 1
    Alkaline phosphatase postoperative month 1 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative month 1
    Gamma-glutamyl transferase postoperative month 1 in the donated recipients (U/Litre)
    Urea postoperative month 1
    Urea postoperative month 1 in the donated recipients (millimol/Litre)
    Bilirubin postoperative month 1
    Bilirubin postoperative month 1 in the donated recipients (micromol/Litre)
    Bilirubin postoperative month 2
    Bilirubin postoperative month 2 in the donated recipients (micromol/Litre)
    Bilirubin postoperative month 3
    Bilirubin postoperative month 3 in the donated recipients (micromol/Litre)
    Bilirubin postoperative month 4
    Bilirubin postoperative month 4 in the donated recipients (micromol/Litre)
    Bilirubin postoperative month 5
    Bilirubin postoperative month 5 in the donated recipients (micromol/Litre)
    Bilirubin postoperative month 6
    Bilirubin postoperative month 6 in the donated recipients (micromol/Litre)
    Bilirubin postoperative month 7
    Bilirubin postoperative month 7 in the donated recipients (micromol/Litre)
    Bilirubin postoperative month 8
    Bilirubin postoperative month 8 in the donated recipients (micromol/Litre)
    Bilirubin postoperative month 9
    Bilirubin postoperative month 9 in the donated recipients (micromol/Litre)
    Bilirubin postoperative month 10
    Bilirubin postoperative month 10 in the donated recipients (micromol/Litre)
    Bilirubin postoperative month 11
    Bilirubin postoperative month 11 in the donated recipients (micromol/Litre)
    Bilirubin postoperative month 12
    Bilirubin postoperative month 12 in the donated recipients (micromol/Litre)
    Urea postoperative month 2
    Urea postoperative month 2 in the donated recipients (millimol/Litre)
    Urea postoperative month 3
    Urea postoperative month 3 in the donated recipients (millimol/Litre)
    Urea postoperative month 4
    Urea postoperative month 4 in the donated recipients (millimol/Litre)
    Urea postoperative month 5
    Urea postoperative month 5 in the donated recipients (millimol/Litre)
    Urea postoperative month 6
    Urea postoperative month 6 in the donated recipients (millimol/Litre)
    Urea postoperative month 7
    Urea postoperative month 7 in the donated recipients (millimol/Litre)
    Urea postoperative month 8
    Urea postoperative month 8 in the donated recipients (millimol/Litre)
    Urea postoperative month 9
    Urea postoperative month 9 in the donated recipients (millimol/Litre)
    Urea postoperative month 10
    Urea postoperative month 10 in the donated recipients (millimol/Litre)
    Urea postoperative month 11
    Urea postoperative month 11 in the donated recipients (millimol/Litre)
    Urea postoperative month 12
    Urea postoperative month 12 in the donated recipients (millimol/Litre)
    Alanine amino transferase postoperative month 2
    Alanine amino transferase postoperative month 2 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative month 2
    Aspartate amino transferase postoperative month 2 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative month 2
    Alkaline phosphatase postoperative month 2 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative month 2
    Gamma-glutamyl transferase postoperative month 2 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative month 3
    Alanine amino transferase postoperative month 3 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative month 3
    Aspartate amino transferase postoperative month 3 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative month 3
    Alkaline phosphatase postoperative month 3 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative month 3
    Gamma-glutamyl transferase postoperative month 3 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative month 4
    Alanine amino transferase postoperative month 4 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative month 4
    Aspartate amino transferase postoperative month 4 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative month 4
    Alkaline phosphatase postoperative month 4 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative month 4
    Gamma-glutamyl transferase postoperative month 4 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative month 5
    Alanine amino transferase postoperative month 5 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative month 5
    Aspartate amino transferase postoperative month 5 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative month 5
    Alkaline phosphatase postoperative month 5 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative month 5
    Gamma-glutamyl transferase postoperative month 5 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative month 6
    Alanine amino transferase postoperative month 6 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative month 6
    Aspartate amino transferase postoperative month 6 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative month 6
    Alkaline phosphatase postoperative month 6 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative month 6
    Gamma-glutamyl transferase postoperative month 6 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative month 7
    Alanine amino transferase postoperative month 7 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative month 7
    Aspartate amino transferase postoperative month 7 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative month 7
    Alkaline phosphatase postoperative month 7 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative month 7
    Gamma-glutamyl transferase postoperative month 7 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative month 8
    Alanine amino transferase postoperative month 8 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative month 8
    Aspartate amino transferase postoperative month 8 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative month 8
    Alkaline phosphatase postoperative month 8 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative month 8
    Gamma-glutamyl transferase postoperative month 8 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative month 9
    Alanine amino transferase postoperative month 9 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative month 9
    Aspartate amino transferase postoperative month 9 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative month 9
    Alkaline phosphatase postoperative month 9 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative month 9
    Gamma-glutamyl transferase postoperative month 9 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative month 10
    Alanine amino transferase postoperative month 10 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative month 10
    Aspartate amino transferase postoperative month 10 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative month 10
    Alkaline phosphatase postoperative month 10 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative month 10
    Gamma-glutamyl transferase postoperative month 10 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative month 11
    Alanine amino transferase postoperative month 11 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative month 11
    Aspartate amino transferase postoperative month 11 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative month 11
    Alkaline phosphatase postoperative month 11 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative month 11
    Gamma-glutamyl transferase postoperative month 11 in the donated recipients (U/Litre)
    Alanine amino transferase postoperative month 12
    Alanine amino transferase postoperative month 12 in the donated recipients (U/Litre)
    Aspartate amino transferase postoperative month 12
    Aspartate amino transferase postoperative month 12 in the donated recipients (U/Litre)
    Alkaline phosphatase postoperative month 12
    Alkaline phosphatase postoperative month 12 in the donated recipients (U/Litre)
    Gamma-glutamyl transferase postoperative month 12
    Gamma-glutamyl transferase postoperative month 12 in the donated recipients (U/Litre)
    Postoperative microdialysis levels of lactate
    Postoperative microdialysis levels of lactate in transplanted livers the first 14 postoperative days
    Postoperative microdialysis levels of pyruvate
    Postoperative microdialysis levels of pyruvate in transplanted livers the first 14 postoperative days
    Postoperative microdialysis levels of glycerol
    Postoperative microdialysis levels of glycerol in transplanted livers the first 14 postoperative days
    Postoperative microdialysis levels of glucose
    Postoperative microdialysis levels of glucose in transplanted livers the first 14 postoperative days
    Systolic blood pressure
    Systolic blood pressure (millimeter Hg)
    Diastolic blood pressure
    Diastolic blood pressure (millimeter Hg)
    Heart rate
    Heart rate (Beats/minute)
    Vasopressor dosage
    Vasopressor dosage (microgram/kilogram/minutes)
    Patient survival
    Patient survival (days)
    Graft survival
    Graft (censored and uncensored for patient death) survival (days)
    Number of deaths
    Number of deaths first 7 days after transplantation
    Number of retransplantation
    Number of retransplantation first 7 days after transplantation
    Incidens of new onset diabetes after transplantation
    New onset diabetes after transplantation after transplantation. New onset diabetes after transplantation is defined according to the World Health Organization criteria (Report 2003 S5-20).
    Estimated glomerular filtration rate - Renal function
    Estimated glomerular filtration rate according to the 4-variable Modification of Diet in Renal Disease equation.
    The incidence of symptomatic Non-anastomotic Biliary Strictures
    The incidence of symptomatic non-anastomotic biliary strictures
    The incidence of asymptomatic Non-anastomotic Biliary Strictures
    The incidence of asymptomatic non-anastomotic biliary strictures
    The incidence of asymptomatic Non-anastomotic Biliary Strictures
    The incidence of asymptomatic non-anastomotic biliary strictures
    The incidence of symptomatic Non-anastomotic Biliary Strictures
    The incidence of symptomatic non-anastomotic biliary strictures
    The severity of Non-anastomotic Biliary Strictures
    The severity of Non-anastomotic Biliary Strictures based on a scoring system described by Buis et. al (mild, moderate, or severe)
    The location of Non-anastomotic Biliary Strictures
    The location of Non-anastomotic Biliary Strictures is assessed by images of the magnetic resonance cholangiopancreatography
    The incidence of infections
    The incidence of infections leading to administration of antibiotics/antifungal/antiviral treatment
    Lactate level in microdialysate from liver tissue - 4 hours
    Microdialysis lactate level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
    Pyruvate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
    Pyruvate level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
    Glycerol level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
    Glycerol level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
    Glucose level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
    Glucose level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
    Glycerol level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Glycerol level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Lactate level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Lactate level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Glucose level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
    Glucose level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Pyruvate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
    Pyruvate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Glycerol level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
    Glycerol level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Lactate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
    Lactate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Glucose level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours
    Glucose level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Pyruvate level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours
    Pyruvate level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.

    Full Information

    First Posted
    April 4, 2023
    Last Updated
    August 2, 2023
    Sponsor
    Oslo University Hospital
    Collaborators
    South-Eastern Norway Regional Health Authority
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05951231
    Brief Title
    Liver Transplantation After ex Vivo Liver Perfusion
    Acronym
    EVOLVE
    Official Title
    Liver Transplantation After ex Vivo Liver Perfusion - The EVOLVE Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2027 (Anticipated)
    Study Completion Date
    September 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Oslo University Hospital
    Collaborators
    South-Eastern Norway Regional Health Authority

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Today, it is difficult to predict liver function after transplantation and therefore livers where poor function is assumed (marginal livers) become discarded. The study aim is to increase the number of available donor livers, especially for liver cancer patients, by pre-treating and testing marginal ones (extended criteria donor (ECD) livers) liver on a liver perfusion machine. A liver perfusion machine can simulate liver transplantation and enables functional/quality testing before transplantation. The machine will hopefully also make marginal livers more functional by reducing ischemia- & reperfusion injury. A marginal donor liver is perfused ex situ with oxygenated blood from a blood donor on a machine. The liver can be tested here for function using internationally recognized criteria. At the same time, the investigators will carry out analyzes with microdialysis which can give a better picture of organ function and damage. Additionally, various samples of the liver and perfusate will be collected. Liver that achieves criteria for transplantation will be offered to the recipient.
    Detailed Description
    The study is a single-center, prospective, open-label cohort study designed to determine the efficacy of liver perfusion of marginal ECD livers on a perfusion machine before liver transplantation. Donor livers will be preserved with standard cooling followed by three perfusion modes (Dual hypothermic oxygenated machine perfusion (DHOPE) / Controlled oxygenated rewarming (COR) / Normothermic machine perfusion (NMP)), a method used internationally to pre-treating marginal livers before liver transplantation and which able testing of function and quality before a transplantation is performed. Only livers that fulfill international criteria (Groningen criteria) will be approved for Ltx. In this study microdialysis will be used to monitoring the liver during machine perfusion and up to 14 days in the postoperative course to monitor the function of the liver. The hypothesis is that microdialysis will provide a better prediction of liver function than the existing Groeningen criteria. The investigators expect that most included patients, who receive ECD livers perfused on a machine, will receive a postoperative well-functioning liver graft which entails a significant survival benefit. The study is designed as a cohort study because included patients have a very poor prognosis (median overall survival of approx. 6 months) and others treatment options are lacking. The primary objective is to establish definitive, objective criteria for pre-transplant liver function by defining a threshold value for microdialysis parameters (especially lactate) between donor livers that will restore function and those that will not during ex vivo machine perfusion in ECD livers, which are superior to established criteria (Groeningen and Viability testing and transplantation of marginal livers (VITTAL) criteria)). The primary endpoint is microdialysis lactate level between donor livers after 4 hours of normothermic machine perfusion in ECD livers. The follow-up period is 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Transplant; Complications, Transplant; Failure, Liver, Transplant Dysfunction, Transplant; Complication, Rejection, Transplant, Liver Metastases, Liver Cancer
    Keywords
    Liver, Transplantation, Perfusion, Dual-end-ischemic Hypothermic Oxygenated Perfusion, Normothermic Machine Perfusion, Controlled Oxygenated Rewarming, Microdialysis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Single center, prospective, open, observational study
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Liver transplanted patient
    Arm Type
    Active Comparator
    Arm Description
    Patients who are transplanted with an ECD liver after pretreatment with a liver perfusion machine
    Arm Title
    Non-liver transplanted patient
    Arm Type
    No Intervention
    Arm Description
    Patients who are not offered a liver transplantation during the inclusion period
    Intervention Type
    Procedure
    Intervention Name(s)
    Liver transplantation
    Intervention Description
    Patients who receive an ECD liver after an ex-vivo liver perfusion where the liver has been tested for function and approved according to international functional criteria (Groeningen criteria)
    Primary Outcome Measure Information:
    Title
    Lactate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
    Description
    Lactate level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Secondary Outcome Measure Information:
    Title
    Lactate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
    Description
    Microdialysis lactate level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Lactate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Description
    Microdialysis lactate level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Pyruvate level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Description
    Microdialysis pyruvate level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Glycerol level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Description
    Microdialysis glycerol level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Glucose level in microdialysate from liver tissue after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Description
    Microdialysis glucose level in donor liver tissue after 2 hours of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Lactate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Microdialysis lactate level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hour
    Title
    Glycerol level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Microdialysis glycerol level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hour
    Title
    Glucose level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Microdialysis glucose level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hour
    Title
    Pyruvate level in microdialysate from liver tissue after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Microdialysis pyruvate level in donor livers tissue after 1 hour of controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hour
    Title
    Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
    Description
    Microdialysis glucose level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Glucose level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
    Description
    Microdialysis glucose level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
    Description
    Microdialysis pyruvate level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Pyruvate level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
    Description
    Microdialysis pyruvate level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 2.5 hours
    Description
    Microdialysis glycerol level in donor liver tissue after 2.5 hours of normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Glycerol level in microdialysate from liver tissue after normothermic machine perfusion - 4 hours
    Description
    Microdialysis glycerol level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Lactate level in microdialysate from bile after normothermic machine perfusion - 4 hours
    Description
    Microdialysis lactate level from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Lactate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
    Description
    Microdialysis lactate level from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Glucose level in microdialysate from bile after normothermic machine perfusion - 4 hours
    Description
    Microdialysis glucose levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Glucose level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
    Description
    Microdialysis glucose levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Pyruvate level in microdialysate from bile after normothermic machine perfusion - 4 hours
    Description
    Microdialysis pyruvate levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Pyruvate level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
    Description
    Microdialysis pyruvate levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Glycerol level in microdialysate from bile after normothermic machine perfusion - 4 hours
    Description
    Glycerol levels from bile after normothermic machine perfusion - 4 hours in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Glycerol level in microdialysate from bile after normothermic machine perfusion - 2.5 hours
    Description
    Glycerol levels from bile after normothermic machine perfusion - 2.5 hours in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Glycerol level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Glycerol levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
    Time Frame
    1 hour
    Title
    Glucose level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Glucose levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
    Time Frame
    1 hour
    Title
    Lactate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Lactate levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
    Time Frame
    1 hour
    Title
    Pyruvate level in microdialysate from bile after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Pyruvate levels from bile after controlled oxygenated rewarming machine perfusion - 1 hour - in extended criteria donors livers.
    Time Frame
    1 hour
    Title
    Pyruvate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Description
    Pyruvate levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Glycerol level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Description
    Glycerol levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Lactate level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Description
    Lactate levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Glucose level in microdialysate from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Description
    Glucose levels from bile after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours - in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Bile gases pH - 4 hours after normothermic machine perfusion
    Description
    Bile gas pH - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Bile gases pH - 2.5 hours after normothermic machine perfusion
    Description
    Bile gas pH - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Bile gases Lactate - 4 hours after normothermic machine perfusion
    Description
    Bile gas Lactate - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Bile gases Lactate - 2.5 hours after normothermic machine perfusion
    Description
    Bile gas Lactate - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Bile gases Glucose - 4 hours after normothermic machine perfusion
    Description
    Bile gas Glucose - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Bile gases Glucose - 2.5 hours after normothermic machine perfusion
    Description
    Bile gas Glucose - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Bile gases Oxygen (O2) - 4 hours after normothermic machine perfusion
    Description
    Bile gas O2 - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Bile gases O2 - 2.5 hours after normothermic machine perfusion
    Description
    Bile gas O2 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Bile gases carbon dioxide (CO2) - 4 hours after normothermic machine perfusion
    Description
    Bile gas CO2 - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Bile gases CO2 - 2.5 hours after normothermic machine perfusion
    Description
    Bile gas CO2 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Bile gases bicarbonate (HCO3) - 4 hours after normothermic machine perfusion
    Description
    Bile gas HCO3 - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Bile gases HCO3 - 2.5 hours after normothermic machine perfusion
    Description
    Bile gas HCO3 - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Bile gases base excess (BE) - 4 hours after normothermic machine perfusion
    Description
    Bile gas BE - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Ischemia/reperfusion injury - 4 hours after normothermic machine perfusion
    Description
    Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Ischemia/reperfusion damage - 4 hours after normothermic machine perfusion
    Description
    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Ischemia/reperfusion injury - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Ischemia/reperfusion injury in liver biopsies, graded according to Tian Y et al et al, Liver transplant 2015; nil, mild, moderate, and severe. - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Ischemia/reperfusion damage - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Ischemia/reperfusion injury - before machine perfusion
    Description
    Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - before machine perfusion in extended criteria donors livers
    Time Frame
    1 minute
    Title
    Ischemia/reperfusion damage - before machine perfusion
    Description
    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - before machine perfusion in extended criteria donors livers
    Time Frame
    1 minute
    Title
    Ischemia/reperfusion injury - after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe - after controlled oxygenated rewarming machine perfusion - 1 hour in extended criteria donors livers
    Time Frame
    1 hour
    Title
    Ischemia/reperfusion damage - after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - after controlled oxygenated rewarming machine perfusion - 1 hour in extended criteria donors livers
    Time Frame
    1 hour
    Title
    Ischemia/reperfusion injury - 2.5 hours after normothermic machine perfusion
    Description
    Ischemia/reperfusion injury in liver biopsies, graded according to Ali JM et al, Liver transplant 2015; nil, mild, moderate, and severe. - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Ischemia/reperfusion damage - 2.5 hours after normothermic machine perfusion
    Description
    Ischemia/reperfusion damage in liver biopsies, graded according to Suzuki score (Tian Y et al, Stem Cell Research & Therapy, 2016); score 0, 1, 2, 3, (0=none, 4= severe) - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Bile gases BE - 2.5 hours after normothermic machine perfusion
    Description
    Bile gas BE - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Bile gases oxygen saturation (SO2) - 4 hours after normothermic machine perfusion
    Description
    Bile gas SO2- 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Bile gases SO2 - 2.5 hours after normothermic machine perfusion
    Description
    Bile gas SO2- 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Bile gases hemoglobin (Hb)- 4 hours after normothermic machine perfusion
    Description
    Bile gas Hb - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Bile gases Hb - 2.5 hours after normothermic machine perfusion
    Description
    Bile gas Hb - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Bile gases sodium (Na) - 4 hours after normothermic machine perfusion
    Description
    Bile gas Na - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Bile gases Na - 2.5 hours after normothermic machine perfusion
    Description
    Bile gas Na - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Bile gases potassium (K) - 4 hours after normothermic machine perfusion
    Description
    Bile gas K - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Bile gases K - 2.5 hours after normothermic machine perfusion
    Description
    Bile gas K - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Bile gases Calcium (Ca) - 4 hours after normothermic machine perfusion
    Description
    Bile gas Ca - 4 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Bile gases Ca - 2.5 hours after normothermic machine perfusion
    Description
    Bile gas Ca - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Markers of injury, inflammation - 2.5 hours after normothermic machine perfusion
    Description
    Markers of injury, inflammation - 2.5 hours after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    2.5 hours
    Title
    Bile gas lactate 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Bile gas lactate 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Markers of injury, inflammation 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Markers of injury, inflammation 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Bile gas Glucose 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Bile gas Glucose 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Bile gas pH 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Bile gas pH 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Bile gas O2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Bile gas O2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Bile gas CO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Bile gas CO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Bile gas HCO3 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Bile gas HCO3 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Bile gas SO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Bile gas SO2 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Bile gas Hemoglobin 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Bile gas Hemoglobin 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Bile gas Na 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Bile gas Na 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Bile gas K 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Bile gas K 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Bile gas Ca 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Bile gas Ca 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Bile gas BE 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion
    Description
    Bile gas BE 2 hours after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hour
    Title
    Bile gas lactate 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Bile gas lactate 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hours
    Title
    Bile gas Glucose 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Bile gas Glucose 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hours
    Title
    Bile gas pH 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Bile gas pH 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hours
    Title
    Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Markers of injury, inflammation 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hours
    Title
    Bile gas O2 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Bile gas O2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hours
    Title
    Bile gas CO2 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Bile gas CO2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hours
    Title
    Bile gas HCO3 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Bile gas HCO3 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hours
    Title
    Bile gas BE 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Bile gas BE 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hours
    Title
    Bile gas SO2 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Bile gas SO2 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hours
    Title
    Bile gas hemoglobin 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Bile gas hemoglobin 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hours
    Title
    Bile gas Na 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Bile gas Na 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hours
    Title
    Bile gas K 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Bile gas K 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hours
    Title
    Bile gas Ca 1 hour after controlled oxygenated rewarming machine perfusion
    Description
    Bile gas Ca 1 hour after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hours
    Title
    Perfusate gas Ca - during machine perfusion
    Description
    Perfusate gas Ca during machine perfusion in extended criteria donors livers.
    Time Frame
    24 hours
    Title
    Perfusate gas pH - during machine perfusion
    Description
    Perfusate gas pH during machine perfusion in extended criteria donors livers.
    Time Frame
    24 hours
    Title
    Perfusate gas SO2 - during machine perfusion
    Description
    Perfusate gas SO2 during machine perfusion in extended criteria donors livers.
    Time Frame
    24 hours
    Title
    Perfusate gas O2 - during machine perfusion
    Description
    Perfusate gas O2 during machine perfusion in extended criteria donors livers.
    Time Frame
    24 hours
    Title
    Perfusate gas CO2 - during machine perfusion
    Description
    Perfusate gas CO2 during machine perfusion in extended criteria donors livers.
    Time Frame
    24 hours
    Title
    Perfusate gas K - during machine perfusion
    Description
    Perfusate gas K during machine perfusion in extended criteria donors livers.
    Time Frame
    24 hours
    Title
    Perfusate gas Na - during machine perfusion
    Description
    Perfusate gas Na during machine perfusion in extended criteria donors livers.
    Time Frame
    24 hours
    Title
    Perfusate gas BE - during machine perfusion
    Description
    Perfusate gas BE during machine perfusion in extended criteria donors livers.
    Time Frame
    24 hours
    Title
    Perfusate gas HCO3 - during machine perfusion
    Description
    Perfusate gas HCO3 during machine perfusion in extended criteria donors livers.
    Time Frame
    24 hours
    Title
    Perfusate gas hemoglobin - during machine perfusion
    Description
    Perfusate gas hemoglobin during machine perfusion in extended criteria donors livers.
    Time Frame
    24 hours
    Title
    Perfusate gas lactate - during machine perfusion
    Description
    Perfusate gas lactate during machine perfusion in extended criteria donors livers.
    Time Frame
    24 hours
    Title
    Perfusate gas glucose - during machine perfusion
    Description
    Perfusate gas glucose during machine perfusion in extended criteria donors livers.
    Time Frame
    24 hours
    Title
    Postoperative complications
    Description
    According to Clavien Dindo Classification
    Time Frame
    12 months
    Title
    Length of stay
    Description
    Length of initial ICU and initial hospital stay is determined in days of admission following liver transplantation.
    Time Frame
    4 months
    Title
    Machine flow during controlled oxygenated rewarming
    Description
    Machine flow (millilitre/hour)
    Time Frame
    1 hour
    Title
    Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion
    Description
    Machine flow (millilitre/hour)
    Time Frame
    1 hour
    Title
    Machine pressure during controlled oxygenated rewarming
    Description
    Machine pressure ((millimetre Hg))
    Time Frame
    1 hour
    Title
    Machine pressure during Dual-end-ischemic Hypothermic Oxygenated Perfusion
    Description
    Machine pressure ((millimetre Hg))
    Time Frame
    1 hour
    Title
    Machine Fraction of oxygen during controlled oxygenated rewarming
    Description
    Machine fraction of oxygen (%)
    Time Frame
    1 hour
    Title
    Machine Fraction of oxygen Dual-end-ischemic Hypothermic Oxygenated Perfusion
    Description
    Machine fraction of oxygen (%)
    Time Frame
    1 hour
    Title
    Machine Resistance during controlled oxygenated rewarming
    Description
    Machine Resistance (millilitre/minute/millimetre Hg)
    Time Frame
    1 hour
    Title
    Machine Resistance during Dual-end-ischemic Hypothermic Oxygenated Perfusion
    Description
    Machine Resistance (millilitre/minute/millimetre Hg)
    Time Frame
    1 hour
    Title
    Machine flow during Dual-end-ischemic Hypothermic Oxygenated Perfusion
    Description
    Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion flow (millilitre/hour)
    Time Frame
    2 hours
    Title
    Machine flow during normothermic machine perfusion
    Description
    Machine flow during normothermic machine perfusion (millilitre/hour)
    Time Frame
    4 hours
    Title
    Machine flow during normothermic machine perfusion
    Description
    Machine flow during normothermic machine perfusion (millilitre/hour)
    Time Frame
    2.5 hours
    Title
    Machine pressure during normothermic machine perfusion
    Description
    Machine pressure (millimetre Hg)
    Time Frame
    4 hours
    Title
    Machine pressure during normothermic machine perfusion
    Description
    Machine pressure (millimetre Hg)
    Time Frame
    2.5 hours
    Title
    Machine Fraction of oxygen during normothermic machine perfusion
    Description
    Machine fraction of oxygen (%)
    Time Frame
    4 hours
    Title
    Machine Fraction of oxygen during normothermic machine perfusion
    Description
    Machine fraction of oxygen (%)
    Time Frame
    2.5 hours
    Title
    Machine Resistance during normothermic machine perfusion
    Description
    Machine Resistance (millilitre/minute/millimetre Hg)
    Time Frame
    4 hours
    Title
    Machine Resistance during normothermic machine perfusion
    Description
    Machine Resistance (millilitre/minute/millimetre Hg)
    Time Frame
    2.5 hours
    Title
    Total preservation time
    Description
    Total preservation time (machine perfusion time)
    Time Frame
    48 hours
    Title
    Alanine amino transferase in perfusate during machine perfusion
    Description
    Alanine amino transferase in perfusate during machine perfusion (U/Litre)
    Time Frame
    24 hours
    Title
    Aspartate amino transferase in perfusate during machine perfusion
    Description
    Aspartate amino transferase in perfusate during machine perfusion (U/Litre)
    Time Frame
    24 hours
    Title
    Alkaline phosphatase in perfusate during machine perfusion
    Description
    Aspartate amino transferase in perfusate during machine perfusion (U/Litre)
    Time Frame
    24 hours
    Title
    Gamma-glutamyl transferase in perfusate during machine perfusion
    Description
    Gamma-glutamyl transferase in perfusate during machine perfusion (U/Litre)
    Time Frame
    24 hours
    Title
    Urea in perfusate during machine perfusion
    Description
    Urea in perfusate during machine perfusion (millimol/Litre)
    Time Frame
    24 hours
    Title
    Bilirubin in perfusate during machine perfusion
    Description
    Bilirubin in perfusate during machine perfusion (micromol/Litre)
    Time Frame
    24 hours
    Title
    Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in perfusate during machine perfusion
    Description
    Different cytokines/interleukins, endothelium markers, miRNA's in perfusate during machine perfusion
    Time Frame
    24 hours
    Title
    Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in liver tissue during machine perfusion
    Description
    Different cytokines/interleukins, endothelium markers, miRNA's in liver tissue during machine perfusion
    Time Frame
    24 hours
    Title
    Not yet decided types of cytokines/interleukins, endothelium markers, miRNA's in bile during machine perfusion
    Description
    Different cytokines/interleukins, endothelium markers, miRNA's in bile during machine perfusion
    Time Frame
    24 hours
    Title
    Histopathology - liver tissue. Mitochondrial function
    Description
    Histological analysis of parenchymal biopsies which are assessed for mitochondrial function.
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - bile duct. Mitochondrial function
    Description
    Histological analysis of bile duct biopsies which are assessed for mitochondrial function.
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - liver tissue. Perfusion/reperfusion injury
    Description
    Histological analysis of parenchymal biopsies which are assessed for perfusion/reperfusion injury
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - bile duct. Perfusion/reperfusion injury
    Description
    Histological analysis of bile duct biopsies which are assessed for perfusion/reperfusion injury
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - liver tissue. Cell death
    Description
    Histological analysis of parenchymal biopsies which are assessed for cell death
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - bile duct. Cell death
    Description
    Histological analysis of bile duct biopsies which are assessed for cell death
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - liver tissue. Inflammation
    Description
    Histological analysis of parenchymal biopsies which are assessed for inflammation
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - bile duct. Inflammation
    Description
    Histological analysis of bile duct biopsies which are assessed for inflammation
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - liver tissue. Metabolomics
    Description
    Histological analysis of parenchymal biopsies which are assessed for metabolomics
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - bileduct. Metabolomics
    Description
    Histological analysis of bile duct biopsies which are assessed for metabolomics
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - liver tissue. Lipidomics
    Description
    Histological analysis of parenchymal biopsies which are assessed for lipidomics
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - bile duct. Lipidomics
    Description
    Histological analysis of bile duct biopsies which are assessed for lipidomics
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - liver tissue. RNA sequencing
    Description
    Histological analysis of parenchymal biopsies which are assessed for RNA sequencing
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - bile duct. RNA sequencing
    Description
    Histological analysis of bile duct biopsies which are assessed for RNA sequencing
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - liver tissue. Endothelium properties
    Description
    Histological analysis of parenchymal biopsies which are assessed for endothelium properties
    Time Frame
    During machine perfusion - 24 hours
    Title
    Histopathology - bile duct. Endothelium properties
    Description
    Histological analysis of bile duct biopsies which are assessed for endothelium properties
    Time Frame
    During machine perfusion - 24 hours
    Title
    International normalized ratio on postoperative day 7
    Description
    Blood sample from recipient: International normalized ratio on postoperative day 7
    Time Frame
    7 postoperative day
    Title
    Alanine amino transferase postoperative day 0
    Description
    Alanine amino transferase postoperative day 0 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 0
    Title
    Aspartate amino transferase postoperative day 0
    Description
    Aspartate amino transferase postoperative day 0 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 0
    Title
    Alkaline phosphatase postoperative day 0
    Description
    Alkaline phosphatase postoperative day 0 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 0
    Title
    Gamma-glutamyl transferase postoperative day 0
    Description
    Gamma-glutamyl transferase postoperative day 0 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 0
    Title
    Urea postoperative day 0
    Description
    Urea postoperative day 0 in the donated recipients (millimol/Litre)
    Time Frame
    Postoperative day 0
    Title
    Bilirubin postoperative day 0
    Description
    Bilirubin postoperative day 0 in the donated recipients (micromol/Litre)
    Time Frame
    Postoperative day 0
    Title
    Bilirubin postoperative day 1
    Description
    Bilirubin postoperative day 1 in the donated recipients (micromol/Litre)
    Time Frame
    Postoperative day 1
    Title
    Bilirubin postoperative day 2
    Description
    Bilirubin postoperative day 2 in the donated recipients (micromol/Litre)
    Time Frame
    Postoperative day 2
    Title
    Bilirubin postoperative day 3
    Description
    Bilirubin postoperative day 3 in the donated recipients (micromol/Litre)
    Time Frame
    Postoperative day 3
    Title
    Bilirubin postoperative day 4
    Description
    Bilirubin postoperative day 4 in the donated recipients (micromol/Litre)
    Time Frame
    Postoperative day 4
    Title
    Bilirubin postoperative day 5
    Description
    Bilirubin postoperative day 5 in the donated recipients (micromol/Litre)
    Time Frame
    Postoperative day 5
    Title
    Bilirubin postoperative day 6
    Description
    Bilirubin postoperative day 6 in the donated recipients (micromol/Litre)
    Time Frame
    Postoperative day 6
    Title
    Bilirubin postoperative day 7
    Description
    Bilirubin postoperative day 7 in the donated recipients (micromol/Litre)
    Time Frame
    Postoperative day 7
    Title
    Urea postoperative day 1
    Description
    Urea postoperative day 1 in the donated recipients (millimol/Litre)
    Time Frame
    Postoperative day 1
    Title
    Urea postoperative day 2
    Description
    Urea postoperative day 2 in the donated recipients (millimol/Litre)
    Time Frame
    Postoperative day 2
    Title
    Urea postoperative day 3
    Description
    Urea postoperative day 3 in the donated recipients (millimol/Litre)
    Time Frame
    Postoperative day 3
    Title
    Urea postoperative day 4
    Description
    Urea postoperative day 4 in the donated recipients (millimol/Litre)
    Time Frame
    Postoperative day 4
    Title
    Urea postoperative day 5
    Description
    Urea postoperative day 5 in the donated recipients (millimol/Litre)
    Time Frame
    Postoperative day 5
    Title
    Urea postoperative day 6
    Description
    Urea postoperative day 6 in the donated recipients (millimol/Litre)
    Time Frame
    Postoperative day 6
    Title
    Urea postoperative day 7
    Description
    Urea postoperative day 7 in the donated recipients (millimol/Litre)
    Time Frame
    Postoperative day 7
    Title
    Aspartate amino transferase postoperative day 1
    Description
    Aspartate amino transferase postoperative day 1 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 1
    Title
    Alkaline phosphatase postoperative day 1
    Description
    Alkaline phosphatase postoperative day 1 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 1
    Title
    Gamma-glutamyl transferase postoperative day 1
    Description
    Gamma-glutamyl transferase postoperative day 1 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 1
    Title
    Alanine amino transferase postoperative day 2
    Description
    Alanine amino transferase postoperative day 2 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 2
    Title
    Aspartate amino transferase postoperative day 2
    Description
    Aspartate amino transferase postoperative day 2 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 2
    Title
    Alkaline phosphatase postoperative day 2
    Description
    Alkaline phosphatase postoperative day 2 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 2
    Title
    Gamma-glutamyl transferase postoperative day 2
    Description
    Gamma-glutamyl transferase postoperative day 2 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 2
    Title
    Alanine amino transferase postoperative day 3
    Description
    Alanine amino transferase postoperative day 3 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 3
    Title
    Aspartate amino transferase postoperative day 3
    Description
    Aspartate amino transferase postoperative day 3 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 3
    Title
    Alkaline phosphatase postoperative day 3
    Description
    Alkaline phosphatase postoperative day 3 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 3
    Title
    Gamma-glutamyl transferase postoperative day 3
    Description
    Gamma-glutamyl transferase postoperative day 3 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 3
    Title
    Alanine amino transferase postoperative day 4
    Description
    Alanine amino transferase postoperative day 4 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 4
    Title
    Aspartate amino transferase postoperative day 4
    Description
    Aspartate amino transferase postoperative day 4 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 4
    Title
    Alkaline phosphatase postoperative day 4
    Description
    Alkaline phosphatase postoperative day 4 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 4
    Title
    Gamma-glutamyl transferase postoperative day 4
    Description
    Gamma-glutamyl transferase postoperative day 4 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 4
    Title
    Alanine amino transferase postoperative day 5
    Description
    Alanine amino transferase postoperative day 5 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 5
    Title
    Aspartate amino transferase postoperative day 5
    Description
    Aspartate amino transferase postoperative day 5 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 5
    Title
    Alkaline phosphatase postoperative day 5
    Description
    Alkaline phosphatase postoperative day 5 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 5
    Title
    Gamma-glutamyl transferase postoperative day 5
    Description
    Gamma-glutamyl transferase postoperative day 5 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 5
    Title
    Alanine amino transferase postoperative day 6
    Description
    Alanine amino transferase postoperative day 6 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 6
    Title
    Aspartate amino transferase postoperative day 6
    Description
    Aspartate amino transferase postoperative day 6 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 6
    Title
    Alkaline phosphatase postoperative day 6
    Description
    Aspartate amino transferase postoperative day 6 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 6
    Title
    Gamma-glutamyl transferase postoperative day 6
    Description
    Gamma-glutamyl transferase postoperative day 6 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 6
    Title
    Alanine amino transferase postoperative day 7
    Description
    Alanine amino transferase postoperative day 7 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 7
    Title
    Aspartate amino transferase postoperative day 7
    Description
    Aspartate amino transferase postoperative day 7 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 7
    Title
    Alkaline phosphatase postoperative day 7
    Description
    Alkaline phosphatase postoperative day 7 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 7
    Title
    Gamma-glutamyl transferase postoperative day 7
    Description
    Gamma-glutamyl transferase postoperative day 7 in the donated recipients (U/Litre)
    Time Frame
    Postoperative day 7
    Title
    Alanine amino transferase postoperative month 1
    Description
    Alanine amino transferase postoperative month 1 in the donated recipients (U/Litre)
    Time Frame
    1 month after surgery
    Title
    Aspartate amino transferase postoperative month 1
    Description
    Aspartate amino transferase postoperative month 1 in the donated recipients (U/Litre)
    Time Frame
    1 month after surgery
    Title
    Alkaline phosphatase postoperative month 1
    Description
    Alkaline phosphatase postoperative month 1 in the donated recipients (U/Litre)
    Time Frame
    1 month after surgery
    Title
    Gamma-glutamyl transferase postoperative month 1
    Description
    Gamma-glutamyl transferase postoperative month 1 in the donated recipients (U/Litre)
    Time Frame
    1 month after surgery
    Title
    Urea postoperative month 1
    Description
    Urea postoperative month 1 in the donated recipients (millimol/Litre)
    Time Frame
    1 month after surgery
    Title
    Bilirubin postoperative month 1
    Description
    Bilirubin postoperative month 1 in the donated recipients (micromol/Litre)
    Time Frame
    1 month after surgery
    Title
    Bilirubin postoperative month 2
    Description
    Bilirubin postoperative month 2 in the donated recipients (micromol/Litre)
    Time Frame
    2 month after surgery
    Title
    Bilirubin postoperative month 3
    Description
    Bilirubin postoperative month 3 in the donated recipients (micromol/Litre)
    Time Frame
    3 month after surgery
    Title
    Bilirubin postoperative month 4
    Description
    Bilirubin postoperative month 4 in the donated recipients (micromol/Litre)
    Time Frame
    4 month after surgery
    Title
    Bilirubin postoperative month 5
    Description
    Bilirubin postoperative month 5 in the donated recipients (micromol/Litre)
    Time Frame
    5 month after surgery
    Title
    Bilirubin postoperative month 6
    Description
    Bilirubin postoperative month 6 in the donated recipients (micromol/Litre)
    Time Frame
    6 month after surgery
    Title
    Bilirubin postoperative month 7
    Description
    Bilirubin postoperative month 7 in the donated recipients (micromol/Litre)
    Time Frame
    7 month after surgery
    Title
    Bilirubin postoperative month 8
    Description
    Bilirubin postoperative month 8 in the donated recipients (micromol/Litre)
    Time Frame
    8 month after surgery
    Title
    Bilirubin postoperative month 9
    Description
    Bilirubin postoperative month 9 in the donated recipients (micromol/Litre)
    Time Frame
    9 month after surgery
    Title
    Bilirubin postoperative month 10
    Description
    Bilirubin postoperative month 10 in the donated recipients (micromol/Litre)
    Time Frame
    10 month after surgery
    Title
    Bilirubin postoperative month 11
    Description
    Bilirubin postoperative month 11 in the donated recipients (micromol/Litre)
    Time Frame
    11 month after surgery
    Title
    Bilirubin postoperative month 12
    Description
    Bilirubin postoperative month 12 in the donated recipients (micromol/Litre)
    Time Frame
    12 month after surgery
    Title
    Urea postoperative month 2
    Description
    Urea postoperative month 2 in the donated recipients (millimol/Litre)
    Time Frame
    2 month after surgery
    Title
    Urea postoperative month 3
    Description
    Urea postoperative month 3 in the donated recipients (millimol/Litre)
    Time Frame
    3 month after surgery
    Title
    Urea postoperative month 4
    Description
    Urea postoperative month 4 in the donated recipients (millimol/Litre)
    Time Frame
    4 month after surgery
    Title
    Urea postoperative month 5
    Description
    Urea postoperative month 5 in the donated recipients (millimol/Litre)
    Time Frame
    5 month after surgery
    Title
    Urea postoperative month 6
    Description
    Urea postoperative month 6 in the donated recipients (millimol/Litre)
    Time Frame
    6 month after surgery
    Title
    Urea postoperative month 7
    Description
    Urea postoperative month 7 in the donated recipients (millimol/Litre)
    Time Frame
    7 month after surgery
    Title
    Urea postoperative month 8
    Description
    Urea postoperative month 8 in the donated recipients (millimol/Litre)
    Time Frame
    8 month after surgery
    Title
    Urea postoperative month 9
    Description
    Urea postoperative month 9 in the donated recipients (millimol/Litre)
    Time Frame
    9 month after surgery
    Title
    Urea postoperative month 10
    Description
    Urea postoperative month 10 in the donated recipients (millimol/Litre)
    Time Frame
    10 month after surgery
    Title
    Urea postoperative month 11
    Description
    Urea postoperative month 11 in the donated recipients (millimol/Litre)
    Time Frame
    11 month after surgery
    Title
    Urea postoperative month 12
    Description
    Urea postoperative month 12 in the donated recipients (millimol/Litre)
    Time Frame
    12 month after surgery
    Title
    Alanine amino transferase postoperative month 2
    Description
    Alanine amino transferase postoperative month 2 in the donated recipients (U/Litre)
    Time Frame
    2 month after surgery
    Title
    Aspartate amino transferase postoperative month 2
    Description
    Aspartate amino transferase postoperative month 2 in the donated recipients (U/Litre)
    Time Frame
    2 month after surgery
    Title
    Alkaline phosphatase postoperative month 2
    Description
    Alkaline phosphatase postoperative month 2 in the donated recipients (U/Litre)
    Time Frame
    2 month after surgery
    Title
    Gamma-glutamyl transferase postoperative month 2
    Description
    Gamma-glutamyl transferase postoperative month 2 in the donated recipients (U/Litre)
    Time Frame
    2 month after surgery
    Title
    Alanine amino transferase postoperative month 3
    Description
    Alanine amino transferase postoperative month 3 in the donated recipients (U/Litre)
    Time Frame
    3 month after surgery
    Title
    Aspartate amino transferase postoperative month 3
    Description
    Aspartate amino transferase postoperative month 3 in the donated recipients (U/Litre)
    Time Frame
    3 month after surgery
    Title
    Alkaline phosphatase postoperative month 3
    Description
    Alkaline phosphatase postoperative month 3 in the donated recipients (U/Litre)
    Time Frame
    3 month after surgery
    Title
    Gamma-glutamyl transferase postoperative month 3
    Description
    Gamma-glutamyl transferase postoperative month 3 in the donated recipients (U/Litre)
    Time Frame
    3 month after surgery
    Title
    Alanine amino transferase postoperative month 4
    Description
    Alanine amino transferase postoperative month 4 in the donated recipients (U/Litre)
    Time Frame
    4 month after surgery
    Title
    Aspartate amino transferase postoperative month 4
    Description
    Aspartate amino transferase postoperative month 4 in the donated recipients (U/Litre)
    Time Frame
    4 month after surgery
    Title
    Alkaline phosphatase postoperative month 4
    Description
    Alkaline phosphatase postoperative month 4 in the donated recipients (U/Litre)
    Time Frame
    4 month after surgery
    Title
    Gamma-glutamyl transferase postoperative month 4
    Description
    Gamma-glutamyl transferase postoperative month 4 in the donated recipients (U/Litre)
    Time Frame
    4 month after surgery
    Title
    Alanine amino transferase postoperative month 5
    Description
    Alanine amino transferase postoperative month 5 in the donated recipients (U/Litre)
    Time Frame
    5 month after surgery
    Title
    Aspartate amino transferase postoperative month 5
    Description
    Aspartate amino transferase postoperative month 5 in the donated recipients (U/Litre)
    Time Frame
    5 month after surgery
    Title
    Alkaline phosphatase postoperative month 5
    Description
    Alkaline phosphatase postoperative month 5 in the donated recipients (U/Litre)
    Time Frame
    5 month after surgery
    Title
    Gamma-glutamyl transferase postoperative month 5
    Description
    Gamma-glutamyl transferase postoperative month 5 in the donated recipients (U/Litre)
    Time Frame
    5 month after surgery
    Title
    Alanine amino transferase postoperative month 6
    Description
    Alanine amino transferase postoperative month 6 in the donated recipients (U/Litre)
    Time Frame
    6 month after surgery
    Title
    Aspartate amino transferase postoperative month 6
    Description
    Aspartate amino transferase postoperative month 6 in the donated recipients (U/Litre)
    Time Frame
    6 month after surgery
    Title
    Alkaline phosphatase postoperative month 6
    Description
    Alkaline phosphatase postoperative month 6 in the donated recipients (U/Litre)
    Time Frame
    6 month after surgery
    Title
    Gamma-glutamyl transferase postoperative month 6
    Description
    Gamma-glutamyl transferase postoperative month 6 in the donated recipients (U/Litre)
    Time Frame
    6 month after surgery
    Title
    Alanine amino transferase postoperative month 7
    Description
    Alanine amino transferase postoperative month 7 in the donated recipients (U/Litre)
    Time Frame
    7 month after surgery
    Title
    Aspartate amino transferase postoperative month 7
    Description
    Aspartate amino transferase postoperative month 7 in the donated recipients (U/Litre)
    Time Frame
    7 month after surgery
    Title
    Alkaline phosphatase postoperative month 7
    Description
    Alkaline phosphatase postoperative month 7 in the donated recipients (U/Litre)
    Time Frame
    7 month after surgery
    Title
    Gamma-glutamyl transferase postoperative month 7
    Description
    Gamma-glutamyl transferase postoperative month 7 in the donated recipients (U/Litre)
    Time Frame
    7 month after surgery
    Title
    Alanine amino transferase postoperative month 8
    Description
    Alanine amino transferase postoperative month 8 in the donated recipients (U/Litre)
    Time Frame
    8 month after surgery
    Title
    Aspartate amino transferase postoperative month 8
    Description
    Aspartate amino transferase postoperative month 8 in the donated recipients (U/Litre)
    Time Frame
    8 month after surgery
    Title
    Alkaline phosphatase postoperative month 8
    Description
    Alkaline phosphatase postoperative month 8 in the donated recipients (U/Litre)
    Time Frame
    8 month after surgery
    Title
    Gamma-glutamyl transferase postoperative month 8
    Description
    Gamma-glutamyl transferase postoperative month 8 in the donated recipients (U/Litre)
    Time Frame
    8 month after surgery
    Title
    Alanine amino transferase postoperative month 9
    Description
    Alanine amino transferase postoperative month 9 in the donated recipients (U/Litre)
    Time Frame
    9 month after surgery
    Title
    Aspartate amino transferase postoperative month 9
    Description
    Aspartate amino transferase postoperative month 9 in the donated recipients (U/Litre)
    Time Frame
    9 month after surgery
    Title
    Alkaline phosphatase postoperative month 9
    Description
    Alkaline phosphatase postoperative month 9 in the donated recipients (U/Litre)
    Time Frame
    9 month after surgery
    Title
    Gamma-glutamyl transferase postoperative month 9
    Description
    Gamma-glutamyl transferase postoperative month 9 in the donated recipients (U/Litre)
    Time Frame
    9 month after surgery
    Title
    Alanine amino transferase postoperative month 10
    Description
    Alanine amino transferase postoperative month 10 in the donated recipients (U/Litre)
    Time Frame
    10 month after surgery
    Title
    Aspartate amino transferase postoperative month 10
    Description
    Aspartate amino transferase postoperative month 10 in the donated recipients (U/Litre)
    Time Frame
    10 month after surgery
    Title
    Alkaline phosphatase postoperative month 10
    Description
    Alkaline phosphatase postoperative month 10 in the donated recipients (U/Litre)
    Time Frame
    10 month after surgery
    Title
    Gamma-glutamyl transferase postoperative month 10
    Description
    Gamma-glutamyl transferase postoperative month 10 in the donated recipients (U/Litre)
    Time Frame
    10 month after surgery
    Title
    Alanine amino transferase postoperative month 11
    Description
    Alanine amino transferase postoperative month 11 in the donated recipients (U/Litre)
    Time Frame
    11 month after surgery
    Title
    Aspartate amino transferase postoperative month 11
    Description
    Aspartate amino transferase postoperative month 11 in the donated recipients (U/Litre)
    Time Frame
    11 month after surgery
    Title
    Alkaline phosphatase postoperative month 11
    Description
    Alkaline phosphatase postoperative month 11 in the donated recipients (U/Litre)
    Time Frame
    11 month after surgery
    Title
    Gamma-glutamyl transferase postoperative month 11
    Description
    Gamma-glutamyl transferase postoperative month 11 in the donated recipients (U/Litre)
    Time Frame
    11 month after surgery
    Title
    Alanine amino transferase postoperative month 12
    Description
    Alanine amino transferase postoperative month 12 in the donated recipients (U/Litre)
    Time Frame
    12 month after surgery
    Title
    Aspartate amino transferase postoperative month 12
    Description
    Aspartate amino transferase postoperative month 12 in the donated recipients (U/Litre)
    Time Frame
    12 month after surgery
    Title
    Alkaline phosphatase postoperative month 12
    Description
    Alkaline phosphatase postoperative month 12 in the donated recipients (U/Litre)
    Time Frame
    12 month after surgery
    Title
    Gamma-glutamyl transferase postoperative month 12
    Description
    Gamma-glutamyl transferase postoperative month 12 in the donated recipients (U/Litre)
    Time Frame
    12 month after surgery
    Title
    Postoperative microdialysis levels of lactate
    Description
    Postoperative microdialysis levels of lactate in transplanted livers the first 14 postoperative days
    Time Frame
    14 days
    Title
    Postoperative microdialysis levels of pyruvate
    Description
    Postoperative microdialysis levels of pyruvate in transplanted livers the first 14 postoperative days
    Time Frame
    14 days
    Title
    Postoperative microdialysis levels of glycerol
    Description
    Postoperative microdialysis levels of glycerol in transplanted livers the first 14 postoperative days
    Time Frame
    14 days
    Title
    Postoperative microdialysis levels of glucose
    Description
    Postoperative microdialysis levels of glucose in transplanted livers the first 14 postoperative days
    Time Frame
    14 days
    Title
    Systolic blood pressure
    Description
    Systolic blood pressure (millimeter Hg)
    Time Frame
    From 5 min before reperfusion, up to 20 minutes after reperfusion
    Title
    Diastolic blood pressure
    Description
    Diastolic blood pressure (millimeter Hg)
    Time Frame
    From 5 min before reperfusion, up to 20 minutes after reperfusion
    Title
    Heart rate
    Description
    Heart rate (Beats/minute)
    Time Frame
    From 5 min before reperfusion, up to 20 minutes after reperfusion
    Title
    Vasopressor dosage
    Description
    Vasopressor dosage (microgram/kilogram/minutes)
    Time Frame
    From 5 min before reperfusion, up to 20 minutes after reperfusion
    Title
    Patient survival
    Description
    Patient survival (days)
    Time Frame
    Through study completion, an average of 12 months
    Title
    Graft survival
    Description
    Graft (censored and uncensored for patient death) survival (days)
    Time Frame
    Through study completion, an average of 12 months
    Title
    Number of deaths
    Description
    Number of deaths first 7 days after transplantation
    Time Frame
    7 days after transplantation
    Title
    Number of retransplantation
    Description
    Number of retransplantation first 7 days after transplantation
    Time Frame
    7 days after transplantation
    Title
    Incidens of new onset diabetes after transplantation
    Description
    New onset diabetes after transplantation after transplantation. New onset diabetes after transplantation is defined according to the World Health Organization criteria (Report 2003 S5-20).
    Time Frame
    Through study completion, an average of 12 months
    Title
    Estimated glomerular filtration rate - Renal function
    Description
    Estimated glomerular filtration rate according to the 4-variable Modification of Diet in Renal Disease equation.
    Time Frame
    Through study completion, an average of 12 months
    Title
    The incidence of symptomatic Non-anastomotic Biliary Strictures
    Description
    The incidence of symptomatic non-anastomotic biliary strictures
    Time Frame
    6 months
    Title
    The incidence of asymptomatic Non-anastomotic Biliary Strictures
    Description
    The incidence of asymptomatic non-anastomotic biliary strictures
    Time Frame
    6 months
    Title
    The incidence of asymptomatic Non-anastomotic Biliary Strictures
    Description
    The incidence of asymptomatic non-anastomotic biliary strictures
    Time Frame
    12 months
    Title
    The incidence of symptomatic Non-anastomotic Biliary Strictures
    Description
    The incidence of symptomatic non-anastomotic biliary strictures
    Time Frame
    12 months
    Title
    The severity of Non-anastomotic Biliary Strictures
    Description
    The severity of Non-anastomotic Biliary Strictures based on a scoring system described by Buis et. al (mild, moderate, or severe)
    Time Frame
    Through study completion, an average of 12 months
    Title
    The location of Non-anastomotic Biliary Strictures
    Description
    The location of Non-anastomotic Biliary Strictures is assessed by images of the magnetic resonance cholangiopancreatography
    Time Frame
    Through study completion, an average of 12 months
    Title
    The incidence of infections
    Description
    The incidence of infections leading to administration of antibiotics/antifungal/antiviral treatment
    Time Frame
    Through study completion, an average of 12 months
    Title
    Lactate level in microdialysate from liver tissue - 4 hours
    Description
    Microdialysis lactate level in donor liver tissue after 4 hours of normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Pyruvate level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
    Description
    Pyruvate level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Glycerol level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
    Description
    Glycerol level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Glucose level in microdialysate from hilar plate after normothermic machine perfusion - 4 hours
    Description
    Glucose level in microdialysate from hilar plate after normothermic machine perfusion in extended criteria donors livers.
    Time Frame
    4 hours
    Title
    Glycerol level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Description
    Glycerol level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Lactate level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion - 2 hours
    Description
    Lactate level in microdialysate from hilar plate after Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hours
    Title
    Glucose level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Glucose level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hour
    Title
    Pyruvate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Pyruvate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hour
    Title
    Glycerol level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Glycerol level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hour
    Title
    Lactate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion - 1 hour
    Description
    Lactate level in microdialysate from hilar plate after controlled oxygenated rewarming machine perfusion in extended criteria donors livers.
    Time Frame
    1 hour
    Title
    Glucose level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours
    Description
    Glucose level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hour
    Title
    Pyruvate level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers - 2 hours
    Description
    Pyruvate level in microdialysate from hilar plate after of Dual-end-ischemic Hypothermic Oxygenated Perfusion machine perfusion in extended criteria donors livers.
    Time Frame
    2 hour
    Other Pre-specified Outcome Measures:
    Title
    Donor associated variables - age
    Description
    Age of the donor (years)
    Time Frame
    1 hour
    Title
    Donor associated variables - liver steatosis
    Description
    Assessment of liver steatosis (%)
    Time Frame
    1 hour
    Title
    Donor associated variables - gender
    Description
    Gender of donor
    Time Frame
    1 hour
    Title
    Donor associated variables - Body mass index
    Description
    Body mass index of donor (kilogram/meter2)
    Time Frame
    1 hour
    Title
    Donor associated variables - weight of the liver
    Description
    Weight of the liver (gram)
    Time Frame
    1 hour
    Title
    Ischemia time - warm
    Description
    Estimation of warm ischemia time (minutes)
    Time Frame
    12 hour
    Title
    Ischemia time - cold
    Description
    Estimation of cold ischemia time (minutes)
    Time Frame
    12 hour
    Title
    Donor associated variables - Donor risk index
    Description
    Donor risk index score - Increasing donor risk index is associated with higher discard rates among deceased donor livers procured for transplant. Low value of 1= best prognosis. High value of 40 = worst prognosis
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent ≥ 18 years Indication for liver transplantation (one criteria must be met): Colorectal cancer patients who have received 1st and 2nd line chemotherapy where the treatment has been stopped due to progression or toxicity and the patient is not eligible for SECA-2 (Survival Following Liver Transplantation for Patients With Nonresectable Liver-only Colorectal Metastases) study. Hepatocellular carcinoma patients who are not suitable for standard liver transplantation, liver resection or local treatment (Transarterial Chemoembolisation or Selective internal radiotherapy). The patients must have progression or intolerance (toxicity) for immune checkpoint inhibitors or 1st line treatment. Cholangiocarcinoma patients who have progression or intolerance to first-line chemotherapy. Benign liver disease with urgent need for transplantation within months, but no regular graft is available. Life expectancy ≤ 6 months Willing, able and expected cooperation to attend follow-up examinations Patients who have a need for liver transplantation but cannot participate in other transplant studies or participation in another clinical trial with randomization to liver transplantation. For malignant disease the following criteria must be met: Good performance status assessed at the discretion of the treating physician. ECOG (Eastern Cooperative Oncology Group) 0 or 1 Satisfactory blood tests Hemoglobin >8 g/dl Neutrophiles >1.0 (after any Granulocyte colony-stimulating factor) Platelets >75 Bilirubin <1.5 x upper normal level ASAT (Aspartate aminotransferase), ALAT (alanine aminotransferase) <5 x upper normal level Albumin above lower normal level. Exclusion Criteria: Already listed for ordinary Ltx with expectance of getting offered a regular liver graft within a reasonable time-frame. Patients included in the control arm of the SECA-3 study or the Excalibur studies except for the Ltx arm of the Excalibur I study. Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial. Any reason why, in the opinion of the investigator, the patient should not participate.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Søren E Pischke, MD, PhD
    Phone
    45486579
    Ext
    +47
    Email
    s.e.pischke@medisin.uio.no
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Søren E Pischke, MD, PhD
    Organizational Affiliation
    Oslo University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Due to Norwegian laws individual participant data are not shared

    Learn more about this trial

    Liver Transplantation After ex Vivo Liver Perfusion

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